High sensitivity noise immune stethoscope

ABSTRACT

A physiological sensing stethoscope suitable for use in high-noise environments is disclosed. The stethoscope is designed to be substantially matched to the mechanical impedance of monitored physiological activity and substantially mismatched to the mechanical impedance of air-coupled acoustic activity. One embodiment of the stethoscope utilizes a passive acoustic system. Another embodiment utilizes an active Doppler system. The passive and active systems can be combined in one stethoscope enabling switching from a passive mode to an active mode suitable for use in very high-noise environments. The stethoscope is suitable for use in environments having an ambient background noise of 100 dBA and higher. The passive includes a head having a housing, a flexural disc mounted with the housing, and an electromechanical stack positioned between the housing and the flexural disc in contact with the skin of a patient. The active system detects Doppler shifts using a high-frequency transmitter and receiver.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/736,914 filed Nov. 15, 2005, which isincorporated herein by reference.

GOVERNMENT CONTRACT

The United States Government has certain rights to this inventionpursuant to Contract No. DAMD17-02-C-0028 awarded by the U.S. Army.

FIELD OF THE INVENTION

The present invention relates generally to a stethoscope, and moreparticularly, relates to a stethoscope including passive and activemodes of auscultation suitable for use in high-noise environments.

BACKGROUND INFORMATION

Among the most critical and challenging medical problems in theemergency medical, and particularly the aeromedical field, is thedetection and discrimination of heart and breathing sounds of seriouslyinjured patients in environments having high levels of background noise.During the initial stages of diagnosis and/or treatment, the physicianneeds to stabilize or maintain each patient's condition. Effectivestabilization cannot be accomplished without monitoring the heart andrespiration of the patient. Specifically, the patient may be susceptibleto shock, which can be detected by monitoring vital signs, includingheart rate, respiration and blood pressure. In addition, if the patienthas experienced chest trauma, the detection and monitoring ofrespiration is critical for treating possible lung collapse orconditions causing the lungs to fill with fluid. When this occurs andthe patient is intubated effective tube placement and integrity needs tobe monitored.

Severely injured patients are often evacuated by helicopter to a remotelocation for proper treatment. For example, patients injured in thefield during combat are often evacuated to a remote treating area by aBlackhawk UH-60 helicopter. Traditional auscultation devices have provedineffective in accurately monitoring a patient's heart and breathingsounds when high levels of background noise, such as those created byhelicopters, are present. Background noise can comprise airborneacoustic waves as well as structure borne sounds and vibrations whichcouple to the patient's body. The noise level generated by a BlackhawkUH-60 helicopter, for example, can exceed 100 dBA. Conventional acousticand electronic stethoscopes cannot reliably detect heart sounds orrespiration under these conditions, making it impossible to discriminatesubtle features in either physiological signal.

The background noise can include discrete frequencies, broadband noiseand/or a combination of both. All of these components may be present invarying degrees in high-noise environments such as battlefields andcivilian emergency medical services (EMS) sites. Noise can interferewith the physiological sounds a user wishes to hear through astethoscope because there are several leakage pathways including,through and around the earpieces, through the acoustic tube connectingthe earpieces with the stethoscope head (via mechanical coupling),between the stethoscope head and the patient's body, and through thepatient's body directly into the stethoscope head via mechanicalcoupling between a vibrating transport vehicle and the patient's body.

Although passive acoustic stethoscopes can be functional in environmentshaving a background noise of up to about 80 dBA, medical professionalsoften need to ascertain physiological patient information inenvironments having higher levels of background noise.

Accordingly, a need remains for a stethoscope having both an acousticamplifying system and an active Doppler physiological activity detectionsystem that is effective in high background noise environments andovercomes the limitations, disadvantages, or shortcomings of knownauscultation devices.

The high acoustic background noise of military and civilian helicoptersand other medical transport vehicles require that ear protection be usedby treating physicians. Hence the stethoscope earpieces must beintegrated in some manner with the ear protection. For example, in theArmy, Communication Ear Plugs (CEPs) placed directly into the externalear canal are used to reduce noise leakage from the surrounding air intothe ears while directing communication signals into miniature speakersin-situ in the plug. Replacement of the conventional acoustic tube(hollow pipe) of a normal stethoscope with wires in an electronicstethoscope (which has a transducer in place of the bell and diaphragm)provides an electrical connection that eliminates the noise transmittedthrough the walls of the tube. However, this has no effect on noiseleakage pathways at the transducer where the signal is received. Priorart devices using a microphone inside an air-coupled sensor head do notreduce the noise leakage between the head of the stethoscope and thepatient's body as both the noise and the signal are amplified.

Accordingly, a need remains for a stethoscope that incorporates thecapability to enhance the auscultation of physiological sounds whilerejecting ambient noise.

SUMMARY OF THE INVENTION

The present invention is directed to a highly sensitive physiologicalsensing stethoscope suitable for use in high-noise environments. Thestethoscope can comprise components of a passive acoustic amplifyingsystem, an active acoustic Doppler system and preferably componentscombining the active and passive modalities. The stethoscope is designedto be substantially matched to the impedance of monitored physiologicalsignals and substantially mismatched to the impedance of air-coupledambient energy, such as ambient background noise. The stethoscope issuitable for use in environments having high ambient background noise,e.g., 95 dBA and higher.

The range of physiological frequencies that are accurately reproduced bythe present stethoscope is considerably wider than available from aconventional mechanical bell/diaphragm (air coupled) stethoscope. Thisextended frequency range is achieved without compromising the signal tonoise ratio of the physiological sounds due in part to the impedancematch between the transducer and the tissue compared to the poorimpedance match inherent to the air-coupled interface.

An aspect of the present invention is to provide a stethoscopecomprising a housing including an inner cavity, a flexural disc mountedon the housing structured and arranged to deflect based uponphysiological activity of a patient, and an electromechanical stackpositioned at least partially within the inner cavity mechanicallycoupled between the housing and the flexural disc which generates anelectrical signal upon deflection of the flexural disc.

Another aspect of the present invention is to provide a stethoscopecomprising a housing, an electromechanical stack positioned within thehousing, and means for mechanically amplifying physiological signals incommunication with the electromechanical stack.

A further aspect of the present invention is to provide a stethoscopecomprising a housing having an interior and a longitudinal axis, atransducer capable of converting mechanical energy into an electricalsignal positioned within the housing wherein the transducer has alongest dimension substantially collinear with the longitudinal axis,means for mechanically amplifying forces exerted by physiologicalactivity in communication with the transducer, and means for amplifyingthe electrical signal of the transducer.

Another aspect of the present invention is to provide a stethoscopecomprising a housing, a passive system incorporated into the housing,the passive system comprising an acoustic transducer, an active systemincorporated into the housing, the active system comprising atransmitter an a receiver, and a switch in communication with thepassive system and the active system, the switch able to select thepassive system or active system.

A further aspect of the present invention is to provide a stethoscopecapable of use in a high amplitude ambient noise environment comprisinga housing, an active system incorporated into the housing, the activesystem comprising a transmitter and a receiver for sending and receivinghigh frequency signals to and from a patient exposed to the highamplitude ambient noise environment, and a signal conditioner forreducing or eliminating unwanted signals selected from the highamplitude ambient noise and/or other spurious signals.

Another aspect of the present invention is to provide a method fordetecting physiological activity in a high amplitude ambient noiseenvironment comprising transmitting a high frequency signal into apatient, receiving a reflected signal, demodulating the reflectedsignal, filtering the demodulated signal, and transmitting thedemodulated and filtered signal to an earpiece.

These and other aspects of the present invention will be more fullyunderstood following a review of this specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partially schematic view of an integrated stethoscope havinga head, an electronics box and earpieces in accordance with anembodiment of the present invention.

FIG. 2 is a partially schematic side sectional view of a stethoscopehead in accordance with an embodiment of the present invention.

FIG. 3 is a partially schematic side sectional view of a stethoscopehead in accordance with an embodiment of the present invention.

FIG. 4 is a partially schematic side sectional view of a stethoscopehead in accordance with an embodiment of the present invention.

FIG. 5 is a schematic diagram illustrating electronics in communicationwith an acoustic transducer in accordance with an embodiment of thepresent invention.

FIG. 6 is a partially schematic side sectional view of a stethoscopehead in accordance with an embodiment of the present invention.

FIG. 7 is a bottom view of a stethoscope head in accordance with anembodiment of the present invention.

FIG. 8 is a schematic diagram illustrating a transmitter in accordancewith an embodiment of the present invention.

FIG. 9 is a schematic diagram illustrating a receiver in accordance withan embodiment of the present invention.

FIG. 10 is a schematic diagram illustrating the operation of an activeDoppler stethoscope in accordance with an embodiment of the presentinvention.

FIG. 11 is a schematic diagram illustrating the components of theelectronics box shown in FIG. 1 in accordance with an embodiment of thepresent invention.

FIG. 12 is a partially schematic side sectional view of a stethoscope inaccordance with an embodiment of the present invention.

FIG. 13 is a graphical representation of several heartbeat signalssensed with a stethoscope over a background noise of 90 dBA inaccordance with an embodiment of the present invention.

FIG. 14 is a graphical representation of several heartbeat signalssensed with a stethoscope over a background noise of 100 dBA inaccordance with an embodiment of the present invention.

FIG. 15 is a graphical representation of neonate heart sounds sensedwith a conventional pediatric stethoscope and sensed with a stethoscopein accordance with an embodiment of the present invention.

FIG. 16 is a bar chart illustrating the noise levels used in thereverberant sound chamber of Example 3, which was set up to replicatethe typical spectrum of UH60 Blackhawk helicopter noise.

FIG. 17 is a series of charts illustrating digitally recorded examplesof the output display from a conventional stethoscope and the Dopplerstethoscope of the present invention.

FIG. 18 is a chart illustrating signal to noise ratio for a conventionalstethoscope, a passive embodiment of the present invention and an activeDoppler embodiment of the present invention, as taken from the traces ofExample 3, as the ratio of the signal amplitude during a heart beatcompared to the noise level during the inter-beat interval.

DETAILED DESCRIPTION

The present invention is directed to a stethoscope for detection and/orcharacterization of physiological processes, such as heart andrespiration activity, in high-noise environments. As used herein, theterm “high-noise environment” means a temporary or sustained ambientbackground noise of greater than 80 dBA, for example, at least 90 or 100dBA. High-noise environments can be generated by many sources. Forexample, emergency rescue vehicles, such as fixed and rotary wingaircraft, and emergency ground transport platforms, such as ambulancesmay create a high noise environment. High-noise environments may alsoinclude military combat zones, general ambient city noise, outdooraccident scenes, emergency rooms and trauma centers.

In environments having a background noise level above 80 dBA,unamplified acoustic stethoscopes are largely ineffective for patientdiagnosis. In accordance with an embodiment of the present invention, a“passive” system utilizing amplified acoustics may be used forrelatively high-noise environments, e.g., between ˜80 dBA and 95 dBA. Inaccordance with another embodiment of the present invention an “active”system such as Doppler may be employed in environments with veryhigh-noise, e.g., greater than 95 dBA to allow medical personnel toobtain vital patient respiration and pulmonary information. The precisebackground noise level at which it becomes difficult to discern patientrespiration via auscultation varies widely depending on the user. Moststethoscope users find that acoustic stethoscopes become less effectivein environments having a background noise above 80 dBA.

In one embodiment, an amplified passive acoustic system can be employedin a stethoscope in accordance with the present invention. In anotherembodiment, an active Doppler system can be employed in the stethoscopeof the present invention. In yet another embodiment, both the passiveacoustic system and the active Doppler system can be employed in thestethoscope of the present invention. For example, passive acousticamplification may be desirable for environments where the noise levelsare between 80 and 95 dBA whereas Doppler systems may be desirable fornoise levels beyond 95 dBA. An amplified acoustic system may retain muchmore acoustic information than a Doppler system for purposes ofcharacterization of heart and breath and lung sounds, and uses lesspower. However, when the ambient noise level is too high, and thephysician still needs to know that normal activity is present, theDoppler system may be used.

As shown in FIG. 1, an integrated stethoscope 20, in accordance with anembodiment of the present invention, comprises a head 34, an electronicsbox 28 and earpieces 22. The earpieces 22 can comprise anyconventionally known earpieces suitable for contact with the ear of awearer and capable of transmitting audible sound received by the head 34of the stethoscope 20. The earpieces 22 can be disposed partially withinthe external ear canal or can contact the exterior of the ear of thewearer or may surround the ear as a cup. In one embodiment, thestethoscope 20 comprises only one earpiece 22. Suitable earpiecesinclude Communication Ear Pieces (CEPs), surround ear-pads, headset earpads and the like. The earpiece(s) 22 are connected to an earpiece port26 of the electronic box 28 by any suitable earpiece connection cable24. The electronics box 28 may comprise any suitable housing and signalamplifying, filtering, and/or processing boards capable of acquiringphysiological signals from the stethoscope head 34 and transmittingaudible sound wave signals to the earpiece(s) 22, as will be discussedherein. The electronics box 28 can filter and amplify signals receivedby the head 34, control the volume and frequency of the receivedsignals, control earpiece power, and the like. The electronics box 28comprises a head receiving port 30 capable of receiving the electricalsignals from the stethoscope head 34 that are transmitted along anysuitable head connection cable 32. It may also contain the drivers forDoppler system. In a preferred embodiment, the electronics and batteryare mounted in the stethoscope head.

The head 34 of the stethoscope may have at least one surface that iscapable of contacting the skin of a patient. In one embodiment, thestethoscope head 34 is structured to receive sound waves produced byphysiological processes of a patient, such as heart sounds and breathsounds. In another embodiment, the stethoscope head is structured totransmit ultrasound and receive reflections from anatomical structuressuch as the heart and lungs. The signal processing converts motion ofthese structures into audible signals as will be discussed herein. Asused herein, the term “patient” can include adult, youth and infanthumans as well as animals.

In one passive acoustic embodiment, as shown in FIG. 2, the acousticelements of the stethoscope head 34 comprise an electromechanical stack36 disposed at least partially within the interior 60 of the housing 38.The interior 60 can be hollow or filled with a compressible materialsuch as foam. The electromechanical stack 36 comprises one or moreelectromechanical materials. As used herein, the term “electromechanicalmaterial” means a material that, when activated, produces electricalenergy. As used herein, the term “activated” means that an externalmechanical force is applied to the electromechanical material todistort, deform, compress or extend the electromechanical material.

In one embodiment, a first end 44 of the electromechanical stack 36 isrestrained against an interior surface 46 of the housing 38, and asecond end 48 of the electromechanical stack 36 is engageable with amoveable piston 40 which may constitute part of a mechanical amplifierthat is responsive to physiological signals, such as heart sounds and/orrespiration, of a patient. A flexural disc 42 is mounted on the housing38 in contact with the piston 40. As shown in FIG. 2, theelectromechanical stack may optionally be terminated at an end 44 with aend-piece such as a rubber damper 49 to minimize transmission ofmechanical energy from the environment through housing end 38 a into theelectromechanical stack 36. As used herein, the term “responsive” meansthe mechanical amplifier, which may comprise the moveable piston 40,fulcrums 48 and coupling or flexural disc 42, transmits an externalmechanical force to the electromechanical stack 36 that correlates tothe physiological processes of a patient. For example, the responsivemoveable piston 40 and/or flexural disc 42 can activate theelectromechanical stack 36 by transferring the mechanical energyproduced, for example, by the contraction of muscles of the heart of thepatient and/or the rush of air through a patient's airway and lungsduring respiration, as will be described herein. The flexural disc 42can have an exterior surface 52 that is shaped to enhance contact withthe skin of a patient to allow for responsive communication between thepatient and the stethoscope head 34. Optionally, an interface layer 53may be inserted between the coupling disc and the patient's skin toenhance contact and acoustical transmission, provide a chemical andmoisture barrier layer and minimize patient discomfort. Suitable examplematerials for this layer include polyurethane and acrylonitrilebutadiene styrene (ABS).

As shown in FIG. 3, the interface layer 53 can comprise a protrusion ornipple 53 a located at about the center of the interface layer 53 to aidin the transmission of physiological signals when the stethoscope isplaced on certain areas of the patient such as, for example, theintercostal space between the ribs.

The enhanced performance of the presently described stethoscope in bothhigh-noise and normal ambient noise environments is achieved through acombination of design features that maximize input signal strength fromthe physiological source under scrutiny and concurrently maximize therejection of competing non-physiological signals from the environment.One such feature is a relatively high mass housing as compared to mostcommercially available stethoscopes. In an embodiment of the presentinvention, the housing may have a mass greater than 50 to 100 grams. Inanother embodiment, the housing may have a mass at least half the massof the total weight of the head of the stethoscope, for example thehousing may be 75% by weight of the stethoscope head. For any incomingacoustic signal or vibration, this serves as an inertial mass at theback end of the electromechanical stack and thereby constitutes a goodmechanical ground. Thus, only the front face of the stack (and hence themechanical system ahead of the stack) will deflect dynamically inresponse to an input mechanical vibration at the patient face of thestethoscope. At the same time, the heavy housing provides the sameinertial mass to the ambient airborne sounds, i.e., it will not beexcited by these noises due to its high mechanical impedance, therebyrejecting the ambient noise. In short, the mass of the system greatlyimproves the coupling of the physiological sounds while just aseffectively rejecting the ambient noise, providing a highly enhancedsignal to noise ratio.

Other beneficial features include the material parameters and mechanismthat provide a transition between the very high mechanical impedance ofa typical electromechanical stack and the very low mechanical impedanceof human tissue. A mechanical amplification mechanism as shown in FIG. 2may be used to amplify a very low force while reducing the displacementavailable from the physiological process in order to produce a greatersignal from the stiff electromechanical stack. This is achieved with alever mechanism comprising the flexural disc 42 supported at itsperiphery 42 a on a rim 50 of the housing 38 and contacted with anannular contact ridge 54 of the piston 40. As used herein, the termsflex, flexible, and deflection imply variable deflection over time. Theannular protrusion 50 may be a radially, inwardly, extending rim of thehousing 38. This rim 50 retains the flexural disc 42 within the housing38 while providing a leverage point to counter the force acting on thefulcrum 54. The above referenced transition is also improved by reducingthe stiffness of the stack through use of a sensing element with a highaspect ratio. The higher the length to footprint ratio is, the morecompliant the stack or element is, enabling the mechanical impedance ofthe stack to improve relative to the physiology target the stethoscopeis monitoring. The stiffness of the stack still remains high relative tothe latter, but the gain that is achieved through aspect ratio helpsoptimize the transition between stiff ceramic and physiological sounds.

A benefit deriving from such a design is that the range of physiologicalfrequencies that are accurately reproduced by the present stethoscope isconsiderably wider than what is available from a conventional mechanicalbell/diaphragm (air coupled) stethoscope or a conventional amplified orelectronic stethoscope. This extended frequency range is achieved inpart by having the electronic signal transducer mechanical impedancematched to the impedance of the body tissues being monitored. Thisimpedance match improves both the fidelity of the body sounds beingamplified and the rejection of air borne interference. The design of theelectronic amplifier following the transducer places no limit on thefrequency range or fidelity of the biological sounds. The result is astethoscope that allows a physician to easily hear and identify soundsthat were previously difficult or impossible to resolve with currentstethoscope technology.

Although the effective stiffness of the stack may be reduced throughappropriate changes in element geometry, the beneficial properties ofthe inherently stiff ceramic stack are retained. The stack offers highelectromechanical coupling coefficient and high capacitance. In additionto rejecting platform noise, e.g., from helicopter or ambulance, anadvantage of the present invention to optimize coupling between thephysiological (mechanical) input signals and the electrical outputsignal. The coupling path is divided into two principal steps:mechanical coupling between human tissue and the electromechanicalelement; and the mechanical to electric coupling of the element itself.The latter is defined by the so-called coupling coefficient, k, of theelectromechanical material, where:k ²=[mechanical energy converted to electrical energy]/[input mechanicalenergy]

The electromechanical element will have a preferred orientation, orpoling direction, which is preset and permanent within limits in thecase of piezoelectric materials, or maintained by external bias, usingdc electric field in the case of electrostrictive materials, andmagnetic field, e.g., with embedded permanent magnets, formagnetostrictive materials. For sensing applications the induced voltagefrom the electromechanical element is picked-up either by electrodesattached to faces at opposite ends of the poled direction in thematerial, or in case of magnetostrictive elements by a coil surroundingthe material with its longitudinal axis coincident with the polingdirection.

In mathematical treatments of electromechanical phenomena the poleddirection (z) is referred to by the subscript 3, and the transversedirections (x, y) by the subscripts 1 and 2. Thus when a stress isapplied in the 3 direction and the induced voltage is detected onelectrodes at opposite ends of the 3 direction, the material couplingcoefficient is represented by k₃₃ and its piezoelectric voltagecoefficient by g₃₃. Likewise, when the stress is applied in a transversedirection the voltage at the electrodes on opposite ends of the poledlength will be represented by coefficients k₃₁ and g₃₁. For mostmaterials k₃₃>k₃₁ and g₃₃>g₃₁, and so the most effectiveelectromechanical coupling and sensing is achieved when the stress andinduced electric field (poled direction) are collinear. This case isoften referred to as the 33-mode, and in some cases the thickness mode,and is the preferred mode used in an embodiment of this invention.

The mechanical coupling between human tissue and sensor may be thoughtof as analogous to impedance matching in electrical circuits, except theimpedances are mechanical and mostly governed by material stiffness. Theelectromechanical materials typically have high elastic moduli so thatlarge forces are required to generate strains capable of producingmeasurable voltages across a solid piece of material. In the case of ablock of electromechanical material contacting human tissue, most of theenergy from a physiological sound would compress the tissue at theinterface and then reflect away from the far stiffer block. Little wouldbe coupled to the block to produce a voltage. Piezoelectric polymershave lower moduli and so can be used to enhance mechanical couplingbetween tissue and sensor, however the coupling coefficients of thesematerials are much lower than the stiffer single-crystal or ceramicpiezoelectric and electrostrictive materials.

One conventional approach to increasing the mechanical coupling is toform the electromechanical material into long thin strips or plates andmount them as cantilevers or diaphragms. Such an electromechanicalelement contacting human tissue is far more compliant than the stiffblock since the physiological sound now tends to bend the thin elementrather than directly compress it. However, these designs all utilize the31-mode and so will have lower electromechanical coupling than the33-mode design described herein and are more susceptible to breakage inservice. An objective of this invention is thus to use anelectromechanical element in its 33-mode and to provide a couplingmechanism that will effectively match the mechanical impedance of theelement to that of human tissue at the front face while providing alarge impedance mismatch between the outer face and air to rejectambient noise. While monolithic materials and simple compressive ortensile stresses are primarily described herein, it is also recognizedthat similar benefits may be obtainable by utilizing a compositeelectromechanical element, and that high coupling coefficients can alsobe obtained using the shear mode as is done in commercialaccelerometers.

As shown in FIGS. 2-3, the electromechanical stack 36 can comprise amonolith or single piece of electromechanical material. In oneembodiment, the electromechanical stack 36 has a mass of from about 0.5grams to about 2 grams, a length (height) of from about 10 mm to about25 mm, and a width (thickness) of from about 2 mm to about 4 mm. In oneembodiment, the head 34 comprises an electromechanical stack 36 having alength that is from about 2 to about 6 times greater than the width.

Example electromechanical materials include piezoelectric materials,electrostrictive and magnetostrictive materials. Suitable piezoelectricmaterials include piezoelectric lead zirconate titanate (PZT), quartzcrystal, lithium niobates, barium titanate, lead titanate, leadmeta-niobate, lead magnesium niobate and/or polymeric materials such aspolyvinylidene di-fluoride (PVDF). In one embodiment, PZT can be used asan electromechanical material because of high electromechanical couplingvalues and low cost. Suitable magnetostrictive materials includeTerfenol-D, commercially available from Etrema Products, Inc., Ames,Iowa.

The electromechanical stack 36 can be substantially matched to theimpedance of physiological signals of a patient, and substantiallymismatched to the impedance of air-carried environmental noise since theformer is >2 orders of magnitude greater than the latter. Thematerial(s) comprising the electromechanical stack 36 may be selected toexhibit high mechanical impedance, (i.e., a high force to velocity ratiois required to compress it, relative to human tissue and air (which haseven lower mechanical impedance). By selecting materials that have highmechanical impedance for the electromechanical stack 36, and contactingthe body through a front end mechanical amplifier, energy transferred tothe stethoscope head 34 from physiological processes within thepatient's body are more readily transferred to the electromechanicalstack than energy in the form of ambient background noise propagatedthrough the air that impinges on the head 34 of the stethoscope 20.Accordingly, the stethoscope head 34 can reduce the contribution ofacoustic noise in the signal transmitted to the electronics box 28,shown in FIG. 1. What is occurring in this matching is that theimpedance combination of the mechanical elements and the stack aredesigned to be as close to the impedance of the physiological load aspossible, yielding a maximum signal input from the physiologicalexcitations. Since most electromechanical materials are far stiffer thanhuman tissue, they are not typically well matched to its motion. Inorder to enhance physiological signals and reject ambient noise, a forceamplifying design can be incorporated into the sensor. Mechanicalamplification can be used to improve the impedance match between livingtissue (muscle, fat, skin, etc.) and the electromechanical stack 36. Inone embodiment, a moveable piston 40 and a flexural disc 42 can becircumferentially mounted within the housing 38. The electromechanicalstack 36 can be positioned between the interior surface 46 of thehousing 38 and at least a portion of the moveable piston 40. Themoveable piston 40 and flexural disc 42 can mechanically amplify thephysiological signals of the patient into a higher force or impedancewhen transferred to the electromechanical stack 36.

Examples of suitable materials for the moveable piston 40 includematerials such as aluminum, other metals and composites. In oneembodiment, the moveable piston 40 can have a substantially circularcross-section and at least a portion of the moveable piston 40 cancontact the flexural disc 42. As shown in FIGS. 2-3, the moveable piston40 can comprise a contact ridge 54 positioned proximate to the peripheryof the moveable piston 40 and extending toward a surface of the flexuraldisc 42. The contact ridge 54 is capable of engaging the flexural disc42 when the mechanical force is applied to the flexural disc 42. Thecontact ridge 54 can comprise a continuous circular ring or a pluralityof discrete contact points that are engageable around the periphery ofthe coupling disc 42 when the electromechanical stack 36 is activated.In one embodiment, the diameter of the moveable piston 40 that contactsthe coupling disc 42 is from about 5 mm to about 15 mm.

In one embodiment, the mechanical amplifier is a simple lever mechanismwhere the larger center portion of the flexural disc 42 deflects againstthe retaining edge of the housing 38 using the contact ridge 54 as afulcrum, generating an amplification of the force applied to the discfrom the human tissue to be coupled to the stack. Although the moveablepiston 40 allows for improved impedance matching between thephysiological activity and the electromechanical stack 36, the couplingpath of the physiological signal is still stiff enough, i.e., there issufficient impedance mismatch, between the low impedance characteristicof air and the high impedance electromechanical stack 36, thatair-carried ambient background noise will not readily couple to theelectromechanical stack 36. Accordingly, air carried noise impinging onthe head 34 will be substantially rejected.

As shown in FIGS. 2-3, the flexural disc 42 may be captured within thehousing 38 by an overlapping restraining edge 50. The restraining edge50 can confine the outer periphery 42 a of the flexural disc 42 withinthe housing 38. In one embodiment, the restraining edge 50 overlaps thecoupling disc periphery 42 a such that the amplifications is ˜5 to 1.The design of the flexural disc 42 is determined by the optimumcombination of dimensions and material modulus to provide a mechanismthat is stiff enough, i.e., impedance mismatched, to resist transferringmost air-carried noise, but compliant enough to flex under the influenceof physiological displacements. Some examples of suitable materials forthe flexural disc 42 include steel, aluminum, composites and the like.The exterior surface 52 of the flexural disc 42 can directly contact apatient's skin and, in use, the responsive coupling disc 42 can conveysmall mechanical forces to the moveable piston 40 through engagedcontact with the contact ridge 54. The contact ridge 54 of the moveablepiston 40 can generate a force amplification of the physiological signaltransferred from the flexural disc 42.

In order to further improve the impedance matching of the head 34 to thephysiological processes of the patient, the exterior surface 52 of theflexural disc 42 can be constructed to allow for direct coupling of thepatient's skin to the flexural disc 42 with no air cavity between. Skindirectly excites the flexural disc 42, moveable piston 40 andelectromechanical stack 36 of the head 34 with a greater force andfidelity than it could with an air interface formed between the flexuraldisc 42 and the patient's skin. Accordingly, such a configurationprovides a greater signal to noise ratio and bandwidth. Amplificationand processing of the received acoustic energy is efficient with directcontact between the patient's skin and the flexural disc 42 because thepressure wave received by the flexural disc 42 can be converted directlyinto electrical signals without loss to air. The configurationeliminates the need of conventional “electronic” stethoscopes,comprising an air cavity adjacent a patient's skin and a microphonepick-up, to pass sound through a second lossy interface at the air tomicrophone transduction stage.

The transferred amplified force from the flexural disc 42 and moveablepiston 40 can then compress the electromechanical stack 36 between theinterior surface 46 of the housing 38 and at least a portion of themoveable piston 40. When the electromechanical stack 36 is compressed,an electric charge is produced. The produced electric charge istransferred along wires 45 to a lead 58 which can be connected to thehead connection cable 32 of FIG. 1. In one embodiment, the housing 38can comprise a single outer shell or a plurality of housing pieces 38 aand 38 b which can be held together by a plurality of fasteners 62. Thehousing 38 can comprise a removable end cap 38B which can allow foreasier assembly of the components within the housing 38. Any suitablefastener 62 can be used to join the housing pieces 38 a and 38 b, suchas rivets, pins, screws, and the like.

In another embodiment of the passive device, shown in FIG. 4, the head134 can comprise an electromechanical stack comprising a plurality ofplates of electromechanical material(s) 136 a, 136 b, 136 c, 136 ddisposed within the interior 160 of the housing 138. In one embodiment,two or more plates 136 a and 136 b can comprise the electromechanicalstack.

As shown in FIG. 4, the coupling or flexural disc 142 can be restrainedwithin the housing 138 by restraining edge 150 at the outer periphery ofthe flexural disc 142 a. In order to reduce the possible air spacebetween the patient's skin and the flexural disc 142, an interfacelayer, shown in FIG. 2 as layer 53 and FIG. 3 as layer 53 withprotrusion 53 a, can include a potting compound layer 180 and can bepositioned adjacent the flexural disc 142 as shown. In this embodiment,the outer surface 182 of the potting compound directly contacts thepatient's skin. The potting compound can comprise any suitable materialsufficiently flexible to transfer energy from the patient to theflexural disc 142 without significant signal dissipation. Suitablepotting compounds include low durometer urethane, silicone rubber, orother similar material. In one embodiment, the outer surface 182 of thepotting compound layer 180 can comprise a plurality of small dimples toallow improved contact with the skin of the patient. As described above,the moveable piston 140 can contact the flexural disc 142 along acontact ridge 154 to further amplify the physiological processes of thepatient. A first end 144 of the first plate 136 a in theelectromechanical stack can be restrained against a surface of an endcap 170 secured to the housing 138 by a plurality of fasteners 162, anda second end 148 of the last plate 136 d in the electromechanical stackcan be engageable with the moveable piston 140. When theelectromechanical stack 136 a, 136 b, 136 c and 136 d is activated,electrical leads 178 connected to one or more of the plates 136 a, 136b, 136 c and 136 d allow an electrical charge generated by theelectromechanical stack to be directed through the interior 160 of thehousing 138 via the conduit 176 through the end cap 170 and viaconnector 174 which is in electrical communication with a communicationport 172 for electrically engaging head receiving port 30 for FIG. 1.

In the passive mode the electronics in the electronic box 28 incommunication with the acoustic transducer amplify the sounds from thepatient while substantially maintaining fidelity. Any suitable acousticsound amplification system conventionally employed in stethoscopes canbe used to receive and condition the audio frequency from the mechanicalto electrical transducer.

In one embodiment, the audio preamplifier can be matched to theelectrical impedance of the mechanical to electrical transducer toprovide a gain stage and substantially match the signal impedance to thefollowing functions shown in FIG. 5. A volume control can provide a userselectable control of the volume, such as from zero to maximum gain. Inone embodiment, the audio amplifier can include a fixed gain stage whichamplifies the signal transmitted to a power amplifier such as a Class Dpower amplifier designed to provide up to 1 watt of output power whilemaintaining high efficiency and high fidelity.

In another embodiment of the passive device, as shown in FIG. 6, thestethoscope 320 comprises a housing 338 which contains the stethoscopehead, shown in FIG. 1 as head 34, and the electronics box, shown in FIG.1 as electronics box 28. In this embodiment, the stethoscope 320 can beeasier to manipulate by the physician. The stethoscope 320 comprises anelectromechanical stack 336 having a first end restrained by a baseplate 370 and a second end engageable with a moveable piston 340. Themoveable piston 340 can engage a coupling disc 342, and a pottingcompound layer 372 can be positioned adjacent the coupling disc 342. Anelectronic amplifier board 382 and at least one signal processing board380 can be included in the stethoscope 320 in electrical communication(not shown) with the electric charge produced by the compression of theelectromechanical stack 336 when activated by the moveable piston 340and/or coupling disc 342. Batteries 384 or any other suitable powersupply can be included to provide power to the electronics amplifierboard 382 and/or signal processing board 380. A removable cover 386 canbe positioned within the housing 338 to allow for the exchange of apower supply. Earpieces and electrical connections to earpieces (notshown) can also be included in the stethoscope 320.

As described above, another aspect of the present invention is an activeacoustic Doppler mode stethoscope when auscultation of physiologicalsounds using the passive acoustic stethoscope becomes impossible incompetition with ambient noise, e.g., when noise levels exceed 95 dBA.The Doppler mode provides active interrogation in a frequency band(typically greater than 1 MHz) well above background sounds typical inhigh noise environments and thus avoids any issue of overlap orinterference. In this embodiment, motion of the lung pleura and heartmuscle and vessel walls can be detected well enough to readily assessthe functioning of the respiratory and cardiovascular systems in thepresence of background noise.

The basic Doppler effect for sound operates on the principle that when asource of sound and a receiver of sound move in relation to each other,the pitch or frequency of the sound perceived or detected at thereceiver is different from the pitch or frequency of the source. TheDoppler effect is also produced in echoes, when sound or ultrasound isreflected by, or bounced off of, a moving object. Anatomical structureswithin a patient, such as the heart or lung, reflect ultrasound wavesfrom their walls where an acoustic impedance mismatch occurs and thevelocity of the motion determines the frequency of the echoed ultrasoundwaves. Accordingly, detecting frequency of the echoed ultrasound wavescan be used to measure heart and lung activity. Ultrasound is sound witha frequency greater than the upper limit of human hearing, this limitbeing approximately 20 kHz, for example 1 to 5 MHz for many devices.

In an embodiment utilizing the Doppler mode of the stethoscope of thepresent invention, ultrasound signals transmitted into the body from thehead of the stethoscope are reflected by heart or lung activity withinthe patient and shifted in frequency compared to the transmittedfrequency. The reflected ultrasound waves can be detected by a receiverin the stethoscope head that converts the ultrasound waves intoelectrical signals. The Doppler frequency shift between the directedultrasound waves transmitted by the transmitter and the reflectedultrasound waves received by the receiver varies proportionally with thevelocity of the moving acoustic target within the patient.

As shown in FIG. 7, a stethoscope can include a head 434 comprising atransmitter 470. The transmitter 470 can generate an ultrasound signalthat is mechanically transduced into the body of the patient. In oneembodiment, as shown in FIG. 8, the transmitter 470 can comprise a sinewave oscillator with low harmonic content, and a power amplifier todrive the signal transducer. The transmitter 470 can be located at anylocation on the head 434 of the stethoscope capable of transmittingultrasound signals into the body of the patient. In one embodiment shownin FIG. 12, the transmitter 470 is disposed adjacent a contact surface482 for contacting the skin of a patient.

The transmitting element 470 and receiving element 472 may be cantedinward slightly such that their beam patterns overlap over a depth rangeof interest in the body, for example, <1 in to ˜6 inch. This involvesplacing the face of each element at a slight angle, for example, 1-5°,to the face of the stethoscope head with the outer edge of each elementraised away from the face of the stethoscope head. Thus the transmittedacoustic beam points very slightly inward toward the axis perpendicularto the center of the stethoscope head, and waves reflected from surfacesparallel to the face of the stethoscope head are directed preferentiallytoward the receiving element rather than back to the transmitter. Notethat both elements do not need to be angled inward so long as the anglebetween their two faces is maintained. Thus similar beam geometries andresults can be achieved by locating one element (e.g., transmitter 470)parallel to the face of the stethoscope head and the other (e.g.,receiver 472) canted inward at an angle to the face, for example 2-10°.Once the transmitted ultrasound signal encounters a moving surfacewithin the patient, a reflected signal is generated that is received bythe receiver 472 shown in FIG. 7. The receiver 472 can comprise anysuitable structure capable of receiving reflected signals from thepatient. Typically these are piezoelectric (PZT) sensing elements. Inone embodiment, the receiver 472 is disposed within the head 434 of thestethoscope substantially adjacent the transmitter 470. The receivedsignal is mixed with the transmitted carrier in an FM demodulator toproduce a difference signal corresponding to the heart or lung motion.This is amplified and filtered as shown in FIG. 9.

A principle on which the Doppler relies for rejecting ambient noise isillustrated in FIG. 10. As described above, an ultrasound wave (a) onthe order of 1-5 MHz is transmitted into the body, reflects off movingtissue/organ surfaces and returns (b) to the receiver with slightlychanged frequency. For a traditional Doppler, the precise differencebetween transmitted and received frequencies is determinedelectronically and corresponds to the velocity of the moving surface.While this effect is useful, for example, in police radars forautomobiles traveling in one direction through one medium (air) atrelatively steady velocity, it is not optimum for observing heart andlung walls (constantly changing in velocity and direction) that areembedded in heterogeneous media (bones, fluids, muscle, fat, etc.). Thefeature of interest in the received signal is therefore not the staticfrequency delta but the variation in the frequency with time—orfrequency modulation (FM). Accordingly, any one of a host of standard FMdemodulation techniques can be employed to extract the desired timevarying signal. In one such technique (known as slope detection) thereceived signal comprising the carrier, for example 2 MHz continuouswave ultrasound, plus its time varying Doppler shift components, is runthrough a very sharp filter on the input. The parameters of the filtermay be set in such a way that its peak is close to but separatedslightly from the transmit frequency, hence placing the transmitfrequency at a very steep portion of the amplitude versus frequencycurve. Accordingly, the desired Doppler frequency shifts (temporalvariations in the received frequency compared to the steady statecarrier) are converted to large amplitude changes on the carrier(amplitude modulation—AM). At this point any standard AM detector can beimplemented to detect the baseline signal amplitude to strip out thecarrier and leave just the modulation signal. This modulation signal isa measure of time varying frequency shifts and therefore corresponds tothe desired time varying wall motions.

In the context of operating a Doppler device in high noise, as shown inFIG. 10, the received signal (b) arrives back at the receiver incompetition with two sources of interference—background noise from theenvironment (d) arriving directly at the receiver from the air, andbackground noise/vibration induced in and transmitted through thepatient to the receiver (c) along with the desired reflected ultrasoundsignal. In the above example FM demodulator, signal (d) is eliminatedfrom the Doppler shift detector because its frequency is so low (typicalbackground noise from a helicopter, for example, has a highest amplitudein the range of 50-2500 Hz) that it fails to pass through the sharpfront end filter. Interfering signal (c) represents a quite differentconsideration because any anatomical motion excited by the vehiclevibration or airborne noise should be additive to lung and heart wallmovements and therefore contribute to the “wall velocity” signaldetected by the Doppler shift. In this case, signal (c) is swamped outby the desired wall motion signal because the vehicle vibrations andsounds are very low amplitude compared to the macroscopic movements ofthe outer walls of the heart and lungs. Hence, the Doppler shift isaffected primarily by the latter.

While the above principles underlie the success of the device indetecting heart and lung activity in competition with external sourcesof interference, further refinement was required in the presentinvention to provide satisfactory operation in extremely high noisetransport situations. Simple transmit/receive Doppler delivers a verynoisy signal full of background crackling and artifacts caused bynon-linear velocities of the organs being interrogated and inherent FMdemodulator characteristics. In the presence of low FM signal levels,such as ultrasound reflections from moving tissue, any FM demodulatorwill interpret the background noise floor (in the electronics and in themedium under interrogation) as random frequency changes. These appear atthe output as high amplitude noise and crackles. Elimination of theseeffects is therefore beneficial. Use of the Doppler in a noisyhelicopter relies on the user's ability to manually increase the volumeof the desired Doppler shift signal until it exceeds the backgroundnoise naturally leaking through the wearer's hearing protection and/orheadset. If the Doppler signal is contaminated with artifacts andcrackle then increasing the volume increases these competing soundsequally. Accordingly, in the present invention two filtering stages anda signal realism measure are introduced to produce a very clean, verypure signal corresponding only to the desired wall velocity. Asdescribed in the FM demodulator above, the first filter is applied onthe front end of the ultrasound receiver to limit received signals to avery narrow band around the transmitted frequency thereby eliminatingwide ranges of potential interfering signals from ever entering thereceiver. For example, in one embodiment with a 2 MHz transmitter thereceiver is limited to frequencies of 2 MHz+/−20 kHz. The second filteris applied on the output to the stethoscope headset and limitsfrequencies transmitted to the ear to the range of Doppler shiftsexpected from heart and lung wall velocities. Again this eliminateslarge bands of frequency corresponding to artifacts and other motionswithout physiological significance. This step also enables the sounds tobe restricted to the region of maximum sensitivity of the human ear, forexample 30 Hz to 10 kHz. The final tuning step in the Doppler mode isenhancing the apparent recognizability (or realism) of the signal toassist the medical professional or other user in identifying the sourceof the frequency shift. As mentioned before, the Doppler shift is ameasure of wall velocity. Its frequency and tonal content has noinherent relationship to the underlying physiological process. TheDoppler “sound” corresponding to the advancing and retreating outersurface of the heart bears almost no relation to the whooshing and fluidfilling and clicking sounds that doctors hear from the heart with astandard acoustic stethoscope. The Doppler sound of the advancing andretreating pleura of the outer lung wall is not related in anystraightforward way to the hissing rush of air through the bronchiolesof the lungs or the cavity resonances observed by doctors. Subjectivesetting of bandpass filter limits is therefore helpful in making theDoppler wall motion sounds recognizable to the physician. Iterativeadjustment of filter settings versus physician comments thus produces asignal that is not only audible above background leakage but readilyidentified with a physiological process.

In a preferred embodiment, a passive acoustic system and an activeDoppler system are combined in one stethoscope. The components of theelectronics box 28 shown in FIG. 1 are schematically illustrated asshown in FIG. 11. As shown in FIG. 11, the components of the electronicsbox 28 can include a power supply, a multi-function switch and controllogic, audio switching circuit, and a power amplifier. The power supplycan be a high-efficiency, switch-mode boost power supply that suppliesthe power to the signal generation and conditioning circuitry. Thecontrol logic can consist of discrete static low voltage CMOS, whichconsume little power. In one embodiment, the control logic is powereddirectly from the power supply, such as a battery, and can be always on.This allows the control logic to control the power supply, stethoscopemode and volume controls, even when the power supply is off. This allowsthe user to set the mode of operation of the stethoscope. The mode ofoperation of the stethoscope determines which modality is employed bythe operator. For example, the operator can select the mode of operationto include passive acoustic amplification or the operator can select themode of operation to include transmit/receive Doppler detection. Incertain situations, the operator of the stethoscope may find itdesirable to transition from the passive acoustic mode to the activeDoppler mode, and vice versa. In one embodiment, the operator can selectthe mode of operation of the stethoscope and the desired volume beforeturning the stethoscope on to eliminate high amplitude noise generatedby rubbing contact with the patient. In one embodiment, the stethoscopecan retain the previously used settings to minimize adjustment time. Inanother embodiment, the stethoscope may include a microcomputer in thecontrol logic to enhance functionality.

In another embodiment, the audio switching circuit of the stethoscope ofthe present invention can be a logic-controlled analog switch used togate the audio signal between the various function blocks, shown in FIG.11, as required. The audio power amplifier can be any suitableamplifier, for example a high efficiency, high fidelity, Class Damplifier having a 1-watt output. This allows a high level of audiodrive power with minimal wasted energy.

In another preferred embodiment, the stethoscope head 434 shown in FIG.12 can also include the components of a passive acoustic system,components of the active Doppler system, and all components of thesignal processing control and power supply. As shown in FIG. 12, thestethoscope head 434 can comprise an electromechanical stack 436disposed at least partially within the interior 460 of the housing 438.As described above, an end of the electromechanical stack 436 can berestrained against a rubber portion 484 positioned between an interiorportion of the housing 460 and the electromechanical stack 436. Anotherend of the electromechanical stack 436 is engageable with a moveablepiston 440 and/or a coupling plate 442 that are responsive tophysiological signals, such as heartbeats and/or respiration of apatient.

In the Doppler mode, ultrasound signals may be transmitted by a thindisk of electromechanical material 470 and reflected signals arereceived by the receiver 472. The reflected signals are converted toelectrical signals by the receiver 472 and input to signal conditioningcircuits 474 and electrical interconnect boards 476 where they arefiltered, amplified, demodulated, and further processed to enhance thedetection of heart movement and/or lung movement associated withbreathing. The electrical interconnect boards 476 and the signalconditioning circuits 474 can be connected to a power supply 490, suchas a battery, through a channel 492 within the interior of the housing438. The receiver 472 can comprise a signal transducer, which transmitsto a narrow band tuned amplifier circuit. In one embodiment, an FMdemodulator stage can be included in the circuitry to remove the carriersignal leaving only the audio frequency information corresponding to themovement of the anatomical structure under examination. This in turn canbe followed by a preamp stage that provides both gain and an impedancechange to provide the necessary signal conditioning for the followingstage shown schematically in FIG. 11.

As shown in FIG. 12, a material 480, such as acoustically transparentultrasound isolation foam, can be disposed in contact with the receiver472. The stethoscope head 434 can include any suitable connector (notshown) for transmitting the processed signals to earpieces of thestethoscope. The head 434 can also include any suitable manual controls(not shown) for adjusting the mode, volume and filter of the signal.Although the passive acoustic amplification systems shown in FIGS. 2-4,6 and 12 are directed to a system including an electromechanical stack,it is anticipated that other passive mechanical sound amplifying systemscan be used in association with the present invention. Such systems thatuse PVDF, Terfernol, annealed metglas and other sensors can be envisagedwith associated electronics that are suited to the material selected.For instance, PVDF will require electronics that can accommodate the lowcapacitance of the material; metglas will have to have electronics thatmonitor current output as opposed to voltage since this correlates withforce in magnetic sensors.

It should be noted that the active Doppler and passive acoustic systemsof the present stethoscope may be selected instantaneously with a simpleelectrical switch. Because the passive and active systems operatethrough the same “window”, or outer face of the head of the stethoscope,there is no requirement to turn the stethoscope around or change anaccessory to take advantage of the second mode. Accordingly, a soundthat is detected in passive acoustic mode can immediately beinterrogated for more information with the mode, or vice versa.

EXAMPLE 1

To test the effectiveness of the stethoscope of the present invention, asound generation system was constructed using a signal generator, a B&K2706 75-Watt amplifier, and a JBL #K120 speaker. Noise was generated inthe band of 0.05-1.0 kHz from a recording of a Blackhawk UH-60 and itslevel was monitored by a conventional sound level meter set to “A”weighting. The sensor output at different noise levels was recordedusing a 3562A HP Signal Analyzer and assessed subjectively by volunteerslistening through headphones with CEP's placed under them. As shown inFIGS. 13 and 14, heartbeat sounds were recorded from the chest of avolunteer using the stethoscope of the present invention with 90 dBA and100 dBA background noise levels respectively. Volunteers reported thatthey could hear heartbeats with both the 90 dBA and 100 dBA backgroundnoise. The electromechanical stack transducer of the stethoscope of thepresent invention has a relatively low capacitance (100 pF) andtherefore offers very high electrical impedance at the low frequenciescharacteristic of physiological sounds. To match this to the signalconditioning electronics and hence maintain fidelity, the circuit has avery high input impedance. Accordingly, the stethoscope is optimized tocapture the audible and sub-audible range down to about 10 Hz. Thestethoscope frequency rolls off in the sub-sonic range below 10 Hz dueto the characteristics of the transducer stack. It should be noted,however, that the time domain display in the above referenced figuresdoes not accurately portray the frequencies coming out of thestethoscope below 20 Hz because of limitations in the audio recordingdevice used in this experiment. Much of the heart signal comprisesfrequencies below 20 Hz, and thus the stethoscope output (as opposed tothese visual displays) is an accurate depiction of these sounds.

EXAMPLE 2

A stethoscope in accordance with the present invention was customized tothe unique physiological and anatomical constraints of the pre-terminfant. The device comprised a fingertip applied 10 mm diameterlistening head with a solid state sensing element directly coupled tothe baby's skin. The device was tested and its broadband highsensitivity was found to elucidate the most subtle of physiologicalsounds, some of which cannot be detected by a conventional pediatricstethoscope. An example of heart sounds recorded with the stethoscopedescribed herein, identified as an Active Signal Device, and aconventional pediatric stethoscope is shown in FIG. 15. Subjectively,the clinician's perception of the heart sound was about the same forboth devices, however, FIG. 15 shows that most cardiac acousticinformation lies below about 150 Hz, and the stethoscope of the presentinvention produces 5-10 times the signal amplitude of the conventionalstethoscope in this range. As shown in this example, the uniformresponse across the band of the present invention has a significantadvantage over other conventional devices where the sensitivity rollsoff at both higher and lower frequencies. Another advantage confirmed bythis example is that clinicians have reported new previously inaudiblesounds associated with heart motion and bowel peristalsis when thestethoscope of the present invention is used.

EXAMPLE 3

An integrated acoustic/Doppler stethoscope in accordance with thepresent invention was comparison tested against a high qualityconventional stethoscope (the Littmann Cardiology III) at the AcousticReverberation Chamber of the U.S. Army Aeromedical Research Laboratory(USAARL) at Ft. Rucker, Ala. under the direction of Dr. AdrianusHoutsma. The reverberant sound chamber was set up to replicate thetypical spectrum of UH60 Blackhawk helicopter noise shown in FIG. 16. Itcan be seen that the frequency range of heart and breath soundscorresponds almost exactly to the highest amplitude portion of thehelicopter noise spectrum explaining why conventional acousticstethoscopes are defeated by this environment. The amplitude of thenoise was increased successively from 70 to 110 dBA (the limit of thechamber) while a trained physician auscultated the heart sounds of ahealthy volunteer using Army CEP ear plugs as combined ear protectionand sound conduits. Concurrent with the physician's auscultation, thereceived signal was also digitally recorded for display and calculationpurposes. Some representative examples of the output display from theconventional stethoscope and the Doppler stethoscope of the presentinvention are shown in FIG. 17. At relatively moderate noise levels(70-75 dBA) it can be seen that heart beat signals can be discerned atapproximately 1 second intervals in the traces from both theconventional and Doppler stethoscopes. However, the signal is moreclearly discriminated from the background noise in the Doppler. At 90dBA the background noise becomes a much more significant fraction of thetotal signal for the conventional stethoscope while the Doppler heartbeat signals remain just as far above the noise as at 70 dBA. At 100 dBAthe heart beat signal is essentially lost in the background noise forthe conventional stethoscope whereas the Doppler continues to pick upvery clear signals far above the noise even at 110 dBA. Betterquantification of these results was developed by examining all of thetraces gathered during this series of experiments to calculate signal tonoise S/N) ratios at each ambient noise level. Signal to noise was readoff the traces as the ratio of the signal amplitude during a heart beatcompared to the noise level during the inter-beat interval. FIG. 18shows the results of this analysis. It can be seen that the signal tonoise ratio for the Doppler remains for the most part well above 15 dBAall the way up to a background noise level of 110 dBA. Both the acousticmode of the present stethoscope and the conventional stethoscope fail todetect the heart beat over the noise above about 92 dBA of backgroundnoise. The acoustic mode of the present invention shows an advantage of2-4 dBA versus the conventional stethoscope but this advantage is lostabove a background of 92 dBA.

The results obtained instrumentally and analytically in the aboveexample were confirmed with subjective testing by physician evaluatorsin the same reverberation chamber. Volunteers' heart and breath soundswere monitored using the Doppler mode while the background noise levelwas increased from 90 dBA to 110 dBA, the limit of the chamber. Fourphysicians, including two flight surgeons, monitored several volunteers'and even at the highest levels both lung and heart sounds could be heardclearly enough to establish the proper function of each. Depending uponthe person monitoring, the same auscultation was effective using astandard acoustic stethoscope up to approximately 80 dBA and using theintegrated stethoscope in the passive mode up to ˜95 dBA.

The usefulness of the extended frequency range provided by the presentinvention was shown in pediatric practice (see example 2) wherepreviously inaudible sounds were now heard by the physician potentiallyenabling enhanced diagnosis of pediatric pathologies. Similarly, thedevice was tested on different patients with a collapsed lung(pneumothorax) in a trauma center. The wider frequency range of thepresent stethoscope revealed a high pitched whistle associated with thepneumothorax that had never before been heard with a conventionalstethoscope. Similarly, during testing in a battalion aid station nearBaghdad during the Gulf War an Army surgeon using this device was ableto make a diagnosis of ventricular septal defect in a young Iraqi girl.The subtle murmur associated with this condition could easily have beenmissed in the noisy, bustling environment of this wartime field station.

Whereas particular embodiments of this invention have been describedabove for purposes of illustration, it will be evident to those skilledin the art that numerous variations of the details of the presentinvention may be made without departing from the invention as defined inthe appended claims.

1. A stethoscope, comprising: a housing comprising an inner cavity; aflexural disc mounted on the housing structured and arranged to deflectbased upon physiological activity of a patient; and an electromechanicalstack positioned at least partially within the inner cavity mechanicallycoupled between the housing and the flexural disc which generates anelectrical signal upon deflection of the flexural disc.
 2. Thestethoscope of claim 1, wherein the inner cavity of the housingcomprises a longitudinal axis and the longitudinal axis is substantiallyperpendicular to a plane defined by the flexural disc.
 3. Thestethoscope of claim 2, wherein the electromechanical stack is longestin a dimension substantially collinear with the longitudinal axis. 4.The stethoscope of claim 2, wherein the electromechanical stack has apoled direction and the poled direction is substantially collinear withthe longitudinal axis.
 5. The stethoscope of claim 2, wherein deflectionof the flexural disc towards the inner cavity of the housing causescompression of the electromechanical stack substantially along thelongitudinal axis.
 6. The stethoscope of claim 1, wherein theelectromechanical stack comprises a piezoelectric material and/or amagnetostrictive material.
 7. The stethoscope of claim 1, wherein theelectromechanical stack comprises at least one of piezoelectric leadzirconate titanate, quartz crystal, lithium niobates, barium titanate,lead titanate, meta-lead niobate, lead magnesium niobate, polyvinylidenedi-fluoride, and/or Terfenol-D.
 8. The stethoscope of claim 1, whereinthe electromechanical stack is monolithic or comprises a plurality ofplates.
 9. The stethoscope of claim 8, wherein the electromechanicalstack comprises a first plate comprising a first material and a secondplate comprising a second material.
 10. The stethoscope of claim 1,further comprising a moveable piston positioned between theelectromechanical stack and the flexural disc movable along alongitudinal direction of the housing.
 11. The stethoscope of claim 10,wherein the moveable piston comprises a contact ridge extending from abottom surface of the moveable piston, the contact ridgecircumferentially located near a periphery of the moveable piston andengaging the flexural disc having an edge, the edge in communicationwith the housing, whereby movement of the flexural disc in thelongitudinal direction generates a smaller movement of the moveablepiston in the longitudinal direction.
 12. The stethoscope of claim 1,further including a potting compound layer adjacent the flexural disc.13. The stethoscope of claim 12, wherein the potting compound layerincludes a protrusion extending away from the flexural disc.
 14. Thestethoscope of claim 1, wherein the housing has a mass greater than 100grams.
 15. The stethoscope of claim 1, wherein the housing is greaterthan 75 percent by weight of the stethoscope.
 16. The stethoscope ofclaim 1, wherein the flexural disc is in direct contact with a patient.17. The stethoscope of claim 1, wherein a potting compound layer isadhered to the flexural disc and in direct contact with the patient. 18.A stethoscope, comprising: a housing; an electromechanical stackpositioned within the housing; and means for mechanically amplifyingphysiological signals in communication with the electromechanical stack.19. The stethoscope of claim 18, wherein the means for amplifyingphysiological signals include a flexural disc is in communication withthe housing.
 20. The stethoscope of claim 19, wherein the means foramplifying physiological signals further include a moveable pistonpositioned between the electromechanical stack and the flexural disc.21. The stethoscope of claim 20, wherein the moveable piston includes acontact ridge extending toward the flexural disc.
 22. The stethoscope ofclaim 21, wherein the moveable piston is in pressing contact with theelectromechanical stack.
 23. The stethoscope of claim 18, wherein themeans for amplifying physiological signals generates an amplified signalthat is distinguishable over ambient noise of at least 90 dBA.
 24. Thestethoscope of claim 18, wherein the electromechanical stack comprises apiezoelectric material and/or a magnetostrictive material.
 25. Thestethoscope of claim 18, wherein the electromechanical stack ismonolithic or comprises a plurality of plates.
 26. The stethoscope ofclaim 25, wherein the electromechanical stack comprises a first platecomprising a first piezoelectric material and a second plate comprisinga second piezoelectric material.
 27. A stethoscope, comprising: ahousing having an interior and a longitudinal axis; a transducer capableof converting mechanical energy into an electrical signal positionedwithin the housing, wherein the transducer has a longest dimensionsubstantially collinear with the longitudinal axis; means formechanically amplifying forces exerted by physiological activity incommunication with the transducer; and means for amplifying theelectrical signal of the transducer.
 28. The stethoscope of claim 27,wherein the transducer comprises a piezoelectric material.
 29. Thestethoscope of claim 27, wherein the amplifying means comprises apreamplifier and volume control.
 30. The stethoscope of claim 27,wherein the amplifying means comprises an audio amplifier and a poweramplifier.
 31. The stethoscope of claim 30, wherein the power amplifieris a Class D power amplifier designed to provide up to one watt ofoutput power.
 32. The stethoscope of claim 27, further comprisingbatteries for powering the amplifying means, the batteries containedwithin the housing.
 33. A stethoscope, comprising: a housing; a passivesystem incorporated into the housing, the passive system comprising anacoustic transducer; an active system incorporated into the housing, theactive system comprising a transmitter an a receiver; and a switch incommunication with the passive system and the active system, the switchable to select the passive system or active system.
 34. The stethoscopeof claim 33, wherein the acoustic transducer is an electromechanicalstack.
 35. The stethoscope of claim 33, wherein the acoustic transducercomprises at least one of piezoelectric lead zirconate titanate, quartzcrystal, lithium niobates, barium titanate, lead titanate, meta-leadniobate, lead magnesium niobate, polyvinylidene di-fluoride, and/orTerfenol-D.
 36. The stethoscope of claim 33, wherein the transmittergenerates high frequency signals which are reflected from an objectthereby creating reflected high frequency signals having a frequencyshift dependent on the motion of the object, wherein the receiverdetects the reflected high frequency signals and converts the highfrequency signal into an electrical signal.
 37. The stethoscope of claim33, wherein the passive system is capable of detecting breathing andheartbeat of a patient with ambient noise levels above 85 dBA.
 38. Thestethoscope of claim 33, wherein the active system is capable ofdetecting breathing and heartbeat of a patient at ambient noise levelsgreater than 95 dBA.
 39. The stethoscope of claim 33, wherein the activesystem is capable of detecting breathing and heartbeat of a patient atambient noise levels up to at least 110 dBA.
 40. The stethoscope ofclaim 33, wherein the switch is manually operable.
 41. The stethoscopeof claim 33, wherein the housing has a forward side and a rear side,wherein the passive system and active system are both oriented toreceive input from the forward side.
 42. The stethoscope of claim 33,further comprising an electronics box including a power supply, controllogic, an audio switching circuit, a power amplifier and the switch. 43.A stethoscope capable of use in a high amplitude ambient noiseenvironment, comprising: a housing; an active system incorporated intothe housing, the active system comprising a transmitter and a receiverfor sending and receiving high frequency signals to and from a patientexposed to the high amplitude ambient noise environment; and a signalconditioner for reducing or eliminating unwanted signals selected fromthe high amplitude ambient noise and/or other spurious signals.
 44. Thestethoscope of claim 43, wherein the signal conditioner comprises afront end which receives the high frequency signals from a patient andwherein the front end comprises a demodulator.
 45. The stethoscope ofclaim 44, wherein the high frequency signal is of a selected frequencyand the demodulator comprises a bandpass filter set to pass only thehigh frequency signal within +/−1.0 percent of the selected frequency ofthe high frequency signal.
 46. The stethoscope of claim 44, furthercomprising a bandpass filter following the demodulator which excludesdemodulated signals outside an audible range.
 47. The stethoscope ofclaim 46, wherein the audible range is restricted to about 40 Hz toabout 500 Hz.
 48. The stethoscope of claim 46, further comprising anamplifier to strengthen the demodulated and filtered signal and a useradjusted gain control.
 49. The stethoscope of claim 43, where the highfrequency signal is in the ultrasound range.
 50. A method for detectingphysiological activity in a high amplitude ambient noise environmentcomprising: transmitting a high frequency signal into a patient;receiving a reflected signal; demodulating the reflected signal;filtering the demodulated signal; and transmitting the filtered anddemodulatedsignal to an earpiece.
 51. The method of claim 50, furthercomprising amplifying the demodulated and filtered signal prior to thetransmission to the earpiece.
 52. The method of claim 51, furthercomprising adjusting the gain of the amplified signal prior to thetransmission to the earpiece.